Headgear for masks

ABSTRACT

A headgear for use with a mask includes a first strap being configured to engage a back of a patient&#39;s head and extend on either side of the patient&#39;s parietal bone behind the patient&#39;s ears and assume, in use, a substantially circular or oval shape. At least a portion of the first strap is substantially inextensible. The headgear also includes at least one second strap configured to removably connect the first strap to the mask. The second strap may be more extensible than the first strap. At least a portion of the first strap is self-supporting such that the headgear maintains a three dimensional shape when not in use. The substantially inextensible portion of the first strap is constructed to resiliently return to a predetermined shape when not in use. The arcuate region includes a first portion that may be arranged to align substantially parallel with a top of the patient&#39;s head and a second portion being arranged to align substantially to a rear surface of the patient&#39;s head.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/601,316, filed Jan. 21, 2015, which is a continuation of U.S.application Ser. No. 12/998,420, filed Apr. 19, 2011, now U.S. Pat. No.8,950,404, which is the U.S. national phase of International ApplicationNo. PCT/AU2009/001605, filed Dec. 10, 2009, which designated the U.S.and claims the benefit of Australian Provisional Application Nos. AU2008906390, filed Dec. 10, 2008, AU 2009900327, filed Jan. 29, 2009, AU2009902731, filed Jun. 12, 2009, and AU 2009904236, filed Sep. 4, 2009,each of which is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to headgear and a method of manufacturingthe headgear for use in holding a mask in position on a patient's face,the mask being used for treatment, e.g., of Sleep Disordered Breathing(SDB) with Continuous Positive Airway Pressure (CPAP) or Non-InvasivePositive Pressure Ventilation (NIPPV).

BACKGROUND OF THE INVENTION

Masks used for treatment of SDB such as OSA are typically held on apatient's head by headgear. Headgear typically includes one or moreheadgear straps that are adapted to engage with the mask and hold themask in position on the patient's face. In addition, headgear should becomfortable so that a patient can wear the mask at night while theysleep. There is a continuous need in the art for headgear that iscomfortable, fits a wide range of patients, is easily manufactured, andis inexpensive.

A problem with some prior art headgear is that a given size may fit veryfew patients, or alternatively that they may require a large number ofadjustments to fit. Another problem with some prior art headgear is thatthey have a tendency to leave facial marks in use. Another problem withsome prior art headgear is that they are awkward and complicated to use.

SUMMARY OF THE INVENTION

A first aspect of the present technology is to provide headgear for arespiratory mask.

Another aspect of the present technology is to provide headgear thatcomfortably fits a wide range of patients. Another aspect of the presenttechnology is to provide a lower cost method of manufacturing headgearfor a respiratory mask. Another aspect of the present technology is toprovide a headgear that is easy to use.

One aspect of a headgear in accordance with the present technology isthat a rear portion of the headgear is constructed and arranged toremain relatively fixed in position in use. In one form, the headgearcomprises a rear portion that does not substantially “ride” or slideforward. Another aspect that a preferred headgear does not impinge onthe ears when in use.

In one form the rear portion of the headgear defines a rear loop thatcircumscribes the rear of the head. In one form the rear portioncomprises a rear loop that is substantially inextensible along itslength. In one form of the present technology headgear for a respiratorymask is provided having a first region with a first extensibility and atleast one further region with a different extensibility. In one form theheadgear comprises a generally inextensible rear portion and an elasticside portion.

One aspect of the present technology relates to headgear for use with amask and may include a rigidizer constructed of a rigid or semi-rigidmaterial and adapted to extend on either side of the patient's parietalbone, an upper strap adapted to removably connect the rigidizer to anupper portion of the mask, and a lower strap adapted to removablyconnect the rigidizer to a lower portion of the mask.

Another aspect of the present technology relates to headgear for usewith a mask including a rigidizer constructed of a rigid or semi-rigidmaterial and adapted to extend along the patient's parietal andzygomatic bones, and one or more straps adapted to support the rigidizerat the back of the patient's head.

Another aspect of the present technology relates to headgear comprisinga relatively inextensible rear portion and a plurality of relativelyextensible straps. Preferably in use the relatively extensible strapsinterconnect the rear portion and a mask.

Another aspect of the present headgear technology is a relatively lowcost manufacturing technique.

Another aspect of the present technology relates to method ofconstructing headgear comprising the step of die cutting relativelystraight portions from a sheet of material. Another aspect of thepresent technology relates to a high yield layout of headgear strapcomponents in a sheet.

Another aspect of the present technology may include a method ofmanufacturing headgear for use with a mask, wherein the headgearcomprises components that are generally simple geometric shapes andcapable of being cut from a flat piece of material, wherein the methodincludes: a) cutting multiple components of the same type from a singleflat sheet of said material; b) components are nested against each otheron said sheet to minimize the amount of waste material that is removedand discarded; and c) wherein the method produces a high manufacturingyield. Preferably, the high manufacturing yield is defined by beinggreater than 11.5 headgears per meter² and the shapes may include:generally rectangular or arcuate shapes.

Preferably, the shapes may include: generally rectangular or arcuateshapes; and the components may include: straps or rigidizers.

Another aspect of the present technology may include a headgear assemblyfor use to attach medical equipment to a patient's head, wherein theheadgear comprises: a plurality of elongated straps, wherein at least aportion of said straps includes a rigid or semi-rigid layer encapsulatedbetween a first and second layer of flexible biocompatible material; andfurther wherein a cushioning layer is also encapsulated between thefirst layer of material and the rigid layer. Preferably, the layers ofthe straps are fixed by vulcanization or gluing and the straps mayinclude the rigid layer are positioned to the posterior of the head,when in use. Preferably, the material is fabric.

Another aspect of a headgear in accordance with the present technologyis that it has a lesser tendency to produce facial marks when comparedto prior art. In one form, headgear in accordance with the presenttechnology has softened edges. In one form, joins are located away fromcontact with the face. In one form, large radius edges are used. In oneform, die cut edges are not presented to the face in use.

Another aspect of the present technology may include a process formaking headgear including laminating foam and fabric material to oneanother, thermoforming the laminated foam and fabric material,ultrasonically die cutting the thermoformed and laminated foam andfabric material into one or more strap portions of the headgear, andjoining the one or more strap portions to one another.

Another aspect of a preferred headgear in accordance with the presenttechnology is that it is constructed and arranged to assume apredetermined shape when not in use. The predetermined shape may besubstantially similar to the shape the headgear assumes when being worn,making the headgear intuitively easier to use. In one form, headgear inaccordance with the present technology is constructed and arranged to“spring to life” and assume the predetermined shape when removed frompackaging and/or when a force (e.g. compression) tending to deform theheadgear is removed. In one form the headgear comprises a portionconstructed from a resilient material. In one form the headgearcomprises a self-supporting rear portion.

A further aspect of the present technology relates to a headgear for usewith a mask comprising a rigidizer; a conformable material; and at leastone fabric, wherein edges of the at least one fabric are sealed by atleast one joint so that the rigidizer, the conformable material, and theat least one joint are encapsulated by the at least one fabric over atleast a portion of the headgear.

A still further aspect of the present technology relates to a headgearfor use with a mask comprising a first strap being configured to engagea back of a patient's head and extend on either side of the patient'sparietal bone behind the patient's ears and assume, in use, asubstantially circular or oval shape, wherein at least a portion of thefirst strap is substantially inextensible; and at least one second strapconfigured to removably connect the first strap to the mask.

Another aspect of the present technology relates to a headgear for usewith a mask comprising a first strap being configured to extend over thecrown of a patient's head and extend on either side of the patient'sparietal bone and behind the patient's ears in use; and at least onesecond strap configured to removably connect the first strap to themask, wherein at least a portion of the first strap is self-supportingsuch that the headgear maintains a three dimensional shape when not inuse.

An even further aspect of the present technology relates to a headgearfor holding a respiratory mask in position on a face of a patientcomprising a rear portion; and respective left and right side portionsadapted for connection with the respiratory mask, wherein the rearportion comprises a substantially inextensible arcuate regionconstructed to resiliently return to a predetermined shape when not inuse, the arcuate region including a first portion being arranged toalign substantially parallel with a top of the patient's head and asecond portion being arranged to align substantially to a rear surfaceof the patient's head.

Yet another aspect of the present technology relates to a method ofmanufacturing a headgear for use with a mask comprising placing arigidizer over a first foam and first fabric lamination; placing asecond foam over the rigidizer and a second fabric over the second foam;thermoforming the first foam and the first fabric lamination, therigidizer, the second foam, and the second fabric to form a thermoformedsheet; and ultrasonically cutting the thermoformed sheet around aperimeter of the headgear.

Another aspect of the present technology is to provide one size ofheadgear that fits a wide range of patients, reducing or eliminating theneed to make adjustments to headgear to achieve a fit. In one form ofthe present technology, a rear portion of headgear is provided having afixed size that does not require adjustment to fit a wide range ofpatients.

Other aspects, features, and advantages of this technology will becomeapparent from the following detailed description when taken inconjunction with the accompanying drawings, which are a part of thisdisclosure and which illustrate, by way of example, principles of thisinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings facilitate an understanding of the variousembodiments of this technology. In such drawings:

FIG. 1 is a side view of headgear in position on a patient's headaccording to an embodiment of the present technology;

FIG. 2 is a rear perspective view of headgear in position on a patient'shead according to another embodiment of the present technology;

FIG. 3 is a partial perspective view of headgear according to anotherembodiment of the present technology;

FIG. 4 is a side view of headgear in position on a patient's headaccording to another embodiment of the present technology;

FIG. 4A is a cross-sectional view showing attachment of the headgear ofFIG. 4 to a mask according to an embodiment of the present technology;

FIG. 5 is a side view of headgear in position on a patient's headaccording to another embodiment of the present technology;

FIG. 6 is a rear perspective view of headgear in position on a patient'shead according to another embodiment of the present technology;

FIG. 7 is a front perspective view of the headgear of FIG. 6;

FIG. 8 is a front perspective view of the headgear of FIG. 6 provided toa different mask according to another embodiment of the presenttechnology;

FIG. 9 is a rear perspective view of the headgear arrangement of FIG. 8;

FIG. 10 is a rear perspective view of headgear in position on apatient's head according to another embodiment of the presenttechnology;

FIG. 11 is a perspective view of a rigidizer of the headgear of FIG. 10;

FIG. 12 is an enlarged view showing rigidizer attachment of FIG. 11;

FIG. 13 is a cross-sectional view showing rigidizer attachment of FIG.11;

FIGS. 14A to 14J are cross-sectional views showing alternative materialsand arrangements for a rigidizer according to embodiments of the presenttechnology;

FIG. 15 is a front view of a rigidizer according to an embodiment of thepresent technology.

FIG. 16A shows an example of a relatively high or improved yield nestedheadgear components;

FIG. 16B shows a prior art example of low yield nested headgearcomponents using a prior art method of manufacture;

FIG. 17 is a cross-sectional view of a portion of a strap according to afurther embodiment of the present technology;

FIG. 18 is a cross-sectional top view of a strap according to the sameembodiment depicted in FIG. 17;

FIG. 19 is a top view showing a bulk sheet of material used in themanufacture of the embodiment depicted in FIG. 17;

FIG. 20 is stylized perspective view of the assembled headgear pursuantto the embodiment depicted in FIG. 17;

FIG. 21 is stylized perspective view of the assembled headgear accordingto a further embodiment of the present technology;

FIG. 22 is a rear view of the assembled headgear according to a furtherembodiment of the present technology;

FIG. 23 is stylized perspective view of the assembled headgear accordingto a further embodiment of the present technology;

FIG. 24 is stylized perspective view of the assembled headgear accordingto a further embodiment of the present;

FIG. 25A is a front view of a forehead support according to a furtherembodiment of the present technology;

FIG. 25B is a perspective view of a forehead support according to afurther embodiment of the present technology;

FIG. 25C is a cross section of a forehead support according to a furtherembodiment of the present technology;

FIG. 26 is stylized perspective view of the assembled headgear accordingto a further embodiment of the present technology;

FIG. 27 is rigidizer according to a further embodiment of the presenttechnology;

FIG. 28 is a series of rigidizers nested according to a furtherembodiment of the present technology;

FIG. 29 is top view of the unassembled top strap according to a furtherembodiment of the present technology;

FIG. 30 is top view of the unassembled top strap according to a furtherembodiment of the present technology;

FIG. 31 is a perspective view of an ultrasonically cut headgear strapaccording to an embodiment of the present technology;

FIG. 32 is a perspective view of a headgear strap constructed ofnon-woven material according to an embodiment of the present technology;

FIGS. 33 and 34 show a fabric headgear strap with a foam interioraccording to an embodiment of the present technology;

FIG. 35 shows a method of rigidising with embossed ribs according to anembodiment of the present technology;

FIG. 36 shows alternative positions of the crown strap according to anembodiment of the present technology;

FIG. 37 shows an alternative position of the crown strap according to anembodiment of the present technology;

FIGS. 38 and 39 show headgear with a rigidizer according to anembodiment of the present technology;

FIG. 40 shows a rigidizer according to an embodiment of the technology;

FIG. 41 shows an exemplary process for creating rigidized headgearaccording to an embodiment of the technology;

FIG. 42 shows an exemplary process for creating non-rigidized headgearaccording to an embodiment of the technology; and

FIG. 43 shows headgear including an outer layer of fabric formed aroundor over two cords of material according to an embodiment of thetechnology.

DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS

The following description is provided in relation to several embodimentswhich may share common characteristics and features. It is to beunderstood that one or more features of any one embodiment may becombinable with one or more features of the other embodiments. Inaddition, any single feature or combination of features in any of theembodiments may constitute additional embodiments.

In this specification, the word “comprising” is to be understood in its“open” sense, that is, in the sense of “including”, and thus not limitedto its “closed” sense, that is the sense of “consisting only of”. Acorresponding meaning is to be attributed to the corresponding words“comprise”, “comprised” and “comprises” where they appear. “Rigidizer”means and includes any reinforcing element that increases the rigidityof an another item and may include an object that increases rigidity inone or more axes.

In this specification, a substantially “inextensible” structure will betaken to mean a structure that when subject to the forces normallyencountered in use of a respiratory mask, will have an elongation ofless than about 5%, more preferably less than about 3%.

In this specification a “self-supporting” structure will be taken tomean a structure that can substantially support its own weight under theforce of gravity. Such a self-supporting structure will be contrastedwith a “floppy” structure that is unable to support its own weight undergravity.

In this specification a “rigid” structure is intended to mean astructure relatively more rigid than a “floppy” structure, such as thefabrics typically used as headgear. Such fabrics are typically unable tohold a predefined shape under gravity. A rigid structure may be able toredirect vectors around physical structures such as ears, unlike afloppy fabric that may bend or buckle.

1. Headgear

The figures illustrate headgear according to alternative embodiments ofthe present technology. In the illustrated embodiments, headgear areadapted to be removably attached to a mask to hold and maintain the maskin a desired position on a patient's face. While headgear may beillustrated as being used with a particular type of mask, it should beappreciated that each headgear may be adapted for use with othersuitable masks. That is, the masks are merely exemplary, and eachheadgear embodiment may be adapted for use with any suitable mask, e.g.,full-face mask, nasal mask, mouth mask, nozzles or puffs, nasal prongs,etc, with any suitable configuration, e.g., with or without foreheadsupport.

Also, it should be appreciated that the headgear may be used with a newmask or the headgear may be retrofit to an existing mask.

In embodiments, the headgear arrangement, material, and/or adjustabilitymay be designed to enhance usability, maintenance, comfort, and/oraesthetics. Also, the headgear arrangement, materials, and/oradjustability may be designed to enhance the range of fit, e.g., onesize fits all.

An advantage of a headgear in accordance with the present technology isthat it is relatively self-supporting and/or able to hold its shapewithout being worn. This can make it more intuitive or obvious forpatients to understand how to use the headgear and may contrast withheadgear systems that are entirely floppy and do not retain their shape.In one form the self-supporting aspect of the headgear is provided bythe use of stiffened and/or thickened elements. In another embodiment,the headgear arrangement, material, and/or adjustability may be designedso that e.g., headgear springs out of the box and generally into itsin-use configuration. In addition, the headgear arrangement may hold itsin use shape once out of the box, for example a rigidizer may be formedto maintain the shape of some or part of the headgear.

Advantages to the patient of the present technology may include (but arenot limited to) one or more of the following: a comfortable headgearsystem, a perceived level of comfort and quality, a smooth continuousheadgear shape that is appealing to the consumer, a pillow-likeappearance of the headgear that is soft to touch and comfortable towear, and/or headgear that is pre-formed in the shape it is intended tobe worn and is able to support itself in this shape such that theorientation of the headgear is clear. The orientation of the headgear isclear to the patient as the shape of the headgear is generally curvedmuch like the rear portion of the patient's head. That is, the headgearis generally dome shaped.

In addition, the headgear is able to maintain its shape due to themanufacturing processes employed to construct the headgear and/or thecombination of materials it comprises.

Another aspect of the headgear described herein is to direct the masksystem to direct contact with the patient's face, that is, the vector ofthe headgear may cause the mask to apply pressure perpendicular ornormal to the patient's face.

The headgear may further avoid contacting or obstructing the patient'seyes and ears.

The headgear may also be arranged such that it may fit a wider range ofpatients with only one size.

1.1 Headgear Attachment to Mask

Preferably, each headgear includes two side portions with a rear portionconnecting the side portions. The side portions provide a four-pointattachment with a mask which is consistent with prior headgear, e.g.,allows headgear to be retrofit. However, it should be appreciated thatthe headgear may be structured to provide more or fewer attachmentpoints, e.g., 2 point attachment with a mask, 3 point attachment withthe mask, 5 point attachment with the mask.

In addition, the headgear may be constructed and arranged to provideforce vectors at the mask which are consistent with prior headgear. Forexample, the headgear may be arranged such that the force vectorsapplied by the headgear to the mask are substantially perpendicular tothe mask and substantially parallel to one another (e.g., see FIG. 1).This arrangement enhances the mask seal as the headgear forces the maskdirectly into the patient's face. However, adjustment of the headgearvectors may be necessary, e.g., depending on the type of mask used withthe headgear.

1.2 Rigidizers

The headgear may include one or more rigidizers constructed of a rigidor semi-rigid material that are structured to add rigidity to theheadgear and anchor the headgear in position in use. Rigidizer may beable to bend or deform along its length but resist or prevent stretchingof the headgear in the lengthwise direction of the rigidizer. Therigidizers may be substantially inextensible. The rigidizer may beresilient. A rigidizer in accordance with the present technologypreferably has one or more of the following features:

-   -   holds it shape;    -   allows headgear to redirect seal-force vectors around curves        such as around the eyes, or around the ears;    -   ability to flex; and/or    -   in certain planes provides a structure to maintain a predefined        form.        1.2.1 Rigidizer Positioning

The one or more rigidizers may be configured and positioned to engagealternative regions of the patient's head, e.g., for comfort,aesthetics, usability, etc.

The preferred positioning on the patient head is for the rigidizer toengage the posterior portion of the patient's skull or head.Additionally, it is advantageous not to cover the posterior portion ofthe patient's head to promote comfort whilst the patient is sleeping orin a prone position. Preferably, the rigidizer partially or fullysurrounds or encompasses the parietal and/or occipital regions of thepatient's skull. This rigidizer is preferably mounted in an axis that isapproximately parallel to the orientation of the mask on the patient'sface, when the headgear and mask combination are worn.

1.2.1.1 Parietal Rigidizer

FIGS. 1-3 illustrate headgear including rigidizers structured to conformto either side in a substantially vertical orientation on the patient'sparietal bone to anchor the headgear in position.

Preferably, the rigidizer is relatively not elastic nor extendible alongits length and is generally comprised of material that is resilient innature.

In FIG. 1, a rigidizer 60 is provided on each side of the patient's headwith each rigidizer 60 including an elongated main body 62, a lower arm64 extending generally transverse from a lower end of the main body, andan upper arm 66 extending generally transverse and spaced downwardlyfrom an upper end of the main body. An upper side strap 20 removablyconnects an upper portion of the mask 10 (e.g., via forehead support) tothe upper arm 66, a lower side strap 30 removably connects a lowerportion of the mask 10 (e.g., via headgear clip associated with clipreceptacle) to the lower arm 64, a top strap 40 (e.g., elastic joiningmember) is adapted to pass over the top of the patient's head in use andinterconnect the upper ends of opposing rigidizers 60, and a rear strap50 is adapted to pass behind the patient's head in use and interconnectthe lower ends of opposing rigidizers 60.

In an embodiment, the upper side strap 20 could be a single pieceextending across the patient's forehead from one upper arm 66 to theopposing upper arm 66 on the other side of the patient's head.Preferably, the upper side strap 20 does not extend rearwardlysignificantly past the patient's ears. Also, FIG. 1 illustrates indashed lines a potential extent of the upper and lower arms 66, 64. Inan alternative embodiment, the upper arm 66 may be a single piecestructured to extend across the patient's forehead from one main body 62to the opposing main body 62 on the other side of the patient's head.

In FIG. 2, each rigidizer 260 has a composite construction (as describedbelow) and is arranged such that the upper and lower side straps 220,230 are continuous and extend from upper and lower portions of the mask,and through respective rigidizers 260, which rigidizers 260 extend alongthe parietal bone of the patient's head.

In an embodiment, each of the upper side straps 220, lower side straps230 and rigidizer 260 may have different elastic properties so as toallow adjustability and stability to the mask on the patient's face inuse.

In an example, the upper side strap 220 may be constructed from anextensible material to allow for adjustment of the mask when in use. Forexample, the upper side strap 220 may be made from elastic. Furthermore,the extensibility provided by the upper strap may allow for a greaterfit range of patients. Additionally, the lower side straps 230 may bemade from a material with lower extensibility than that of the upperside strap. That is, the lower side straps 230 may be constructed of amaterial with less stretch for a given force when compared to thematerial used for upper side strap 220. This is to secure the mask inposition while allowing for some adjustment of the mask position on theface of the patient. Furthermore, the rigidizers 260 may be lessextensible and less elastic than upper side strap 220 and/or lower sidestrap 230 so as to provide structure and support to the headgear andthus adequately anchor the mask to the patient's head in use.

Upper side straps 220 and/or lower side straps 230 may be constructedfrom a composite material such as Breath-O-Prene™, and die cut from bulkmaterial. Upper side straps 220 and/or lower side straps 230 may beconstructed from a narrow weave material so as to reduce or eliminatethe waste incurred by die cutting.

In FIG. 3, the rigidizer 360 has a mesh construction adapted to sit overthe patient's occiput. As illustrated, the rigidizer 360 is generallytrapezoidal shaped with an upper end adapted to removably connect toupper side straps 320 associated with an upper portion of the mask and alower end adapted to removably connect to lower side straps 330associated with a lower portion of the mask. The mesh-like rigidizer 360may be flexible to conform to the patient's head yet non-stretch toanchor the headgear in position, for example. However, the mesh may haveother suitable constructions.

In each embodiment, the rigidizers extend generally vertical along theparietal bone of the patient's head and are adapted to cup and/or reston the patient's occiput. As illustrated, the parietal bone rigidizersmay be connected at the top and/or bottom (i.e., in order to sit overthe occiput) and may include additional rigid or semi-rigid componentsto facilitate connection (e.g., see strap connectors in FIGS. 2 and 3).Also, the rigidizers avoid the use of any rigid or semi-rigid componentsat the back of the head where the patient's head would contact the bedin use. Preferably, the rigidizers are flexible or able to conform tothe patient's head along their length, however cannot flex or deformacross their width. This is so that the headgear is comfortable whilstmaintaining its structural function of anchoring the mask in position.

1.2.1.2 Parietal and Zygomatic Rigidizer

FIGS. 4-5 illustrate headgear including rigidizers structured to conformto either side of the patient's parietal bone (i.e., in a generallyvertical orientation) to anchor the headgear in position at the back ofthe patient's head, and extend to the front of the patient's head to thepatient's zygomatic bone.

In FIG. 4, the rigidizer 460 is a continuous component with two sideportions adapted to extend across the mask 10. As illustrated, each sideportion includes an upper strap portion 462 that extends along thepatient's parietal bone over the patient's ear and to the patient'szygomatic bone, and a lower strap portion 464 that extends below thepatient's ear. The upper strap portion 462 extends across an upperportion of the mask 10 and the lower strap portion 464 extends across alower portion of the mask 10.

As shown in FIG. 4A, the upper strap portion 462 may be removablyclipped onto the mask 10. As illustrated, the upper portion of the mask10 may include a plurality of spaced apart slots 15, and a clip 470 mayextend through an opening in the upper strap portion 462 and into aselected one of the slots 15.

A flexible strap arrangement including an upper rear strap 440 and alower rear strap 450 connect the left and right sides of the rigidizers460 at the back of the patient's head. Upper rear strap 440 and lowerrear strap 450 may be a continuous component, or may be separatecomponents.

In FIG. 5, each rigidizer 560 is a continuous component adapted toconnect to a respective side of the mask 10. As illustrated, eachrigidizer 560 includes an upper strap portion 562 that extends along thepatient's parietal bone over the patient's ear and to the patient'szygomatic bone, a lower strap portion 564 that extends below thepatient's ear, and a front strap portion 566 adapted to connect to themask 10.

In the illustrated embodiment, each rigidizer 560 is adapted torotatably engage the side of the mask 10 (e.g., clip onto the side ofthe mask, wrap around anchor on the side of the mask) to allowrotational movement of the mask relative to the rigidizers 560, so thatthe mask can be rotated and adjusted for proper mask fit.

An upper rear strap 540 and a lower rear strap 550 connect the left andright sides of the rigidizers 560 at the back of the patient's head.

1.2.1.3 Occipital and Parietal Rigidizer

FIGS. 6-11 illustrate headgear including rigidizers structured to form asubstantially complete circle/oval shape (e.g., could have an arcremoved at the occiput for adjustability) to anchor the headgear inposition at the back of the patient's head. As illustrated, therigidizers extend along the patient's parietal and occipital bones.

In FIGS. 6-7, the rigidizer 660 includes a substantially circular oroval shape with an arc removed at the lower end. The portion removed atthe lower end may allow adjustment of the size of the circle/oval shape.

An upper side strap 620 removably connects an upper portion of the mask10 (e.g., via forehead support) to the rigidizer and a lower side strap630 removably connects a lower portion of the mask 10 (e.g., viaheadgear clip associated with clip receptacle) to the rigidizer.

Preferably, lower side strap 630 and/or rigidizer 660 engage with theoccipital bone in order to maintain the rigidizer in position andprevent the headgear from riding up the back of the patient's head inuse. In another preferred form, the upper side strap 620 and/orrigidizer 660 could capture or pass over the upper most part of thepatient's parietal bone in use, so as to prevent the headgear fromslipping back down the patient's head in use.

In another embodiment, upper side strap 620 and/or lower side strap 630may have adjustable lengths. This may be achieved through the use of,for example, hook and loop fasteners. The lengths of the upper sidestrap 620 and/or lower side strap 630 should be such that the rigidizer660 does not impinge on the patient's ear. For example, it could bepossible to adjust the length of the upper side strap 620 or lower sidestrap 630 such that the rigidizer is urged towards the patient's face,and thus contacts the ear. This may cause discomfort to the patient.

In another preferred embodiment, lower side strap 630 is threadedthrough apertures in rigidizer 660 such that rigidizer 660 may slidealong the length of lower side strap 630, thereby adjusting the size ofthe space encapsulated by rigidizer 660 and thus altering the shape ofthe headgear to suit different patient's head sizes. In anotherpreferred form, lower side strap 630 may have engaging portions alongits length such that if the size of the space encapsulated by rigidizer660 is adjusted by sliding rigidizer 660 along the length of lower sidestraps 630, the position of the rigidizer 660 on lower side straps 630can be secured in position. For example, engaging portions may be clips,Velcro, raised stitching, or any other means of securing the rigidizer660 in position.

In another preferred embodiment, upper side strap 620, lower side strap630 and/or rigidizer 660 maybe be formed individually such that eachcomponent is manufactured efficiently and cost effectively, (i.e. bynesting the components) as will be described below.

As shown in FIG. 15, rigidizer 660 may be formed from a flat componentand then bent or deformed into a shape suitable for use. Rigidizer 660may be die cut from sheet material. Rigidizer 660 may have upperapertures 2000 for engagement with upper side straps 620. Multiple upperapertures 2000 may be provided (for example, as shown in FIG. 15 thereare 4 apertures) so that the patient can adjust the position of upperside strap 620. Rigidizer 660 may also have lower apertures 2100 forengagement with lower side straps 630.

FIGS. 8-9 show the headgear of FIGS. 6-7 attached to a mask with adifferent configuration. In this embodiment, the upper side strap 620connects to a lateral outrigger of the mask 10 and the lower side strap630 removably connects to the mask 10 via headgear clip associated witha mask clip receptacle. As best shown in FIG. 8, the upper side strap620 may be connected to the lateral outrigger of the mask 10 by anadhesive, so that the upper side strap is adjustable only at therigidizer. Alternatively, the upper side strap 620 may be adjustablyconnected to the slot provided at the end of the lateral outrigger ofthe mask 10, so that the upper side strap may be adjustable at both therigidizer and lateral outrigger.

FIGS. 10-11 show an alternative configuration for attaching therigidizer 660 to the upper and lower side straps 620, 630 as describedbelow.

FIG. 40 shows an alternative arrangement for a rigidizer 7560 adapted tobe positioned along a general rear portion of the patient's head in use.The rigidizer may be formed in a generally light bulb shape, where thereare two generally round or curved portions, i.e., an upper portion 7562adapted to engage the general region of the parietal bone of thepatient's head in use and a lower portion 7564 adapted to engage thegeneral region of the occipital bone of the patient's head in use. Upperstraps 7512 are provided to the upper portion 7562 for engaging an upperportion of a mask, and lower straps 7514 are provided to the lowerportion 7564 for engaging a lower portion of a mask.

1.2.2 Rigidizer/Strap Attachment

The one or more rigidizers may be coupled to the mask and/or with oneanother in alternative configurations.

In an embodiment, each rigidizer may include one or more slots to allowheadgear straps to pass through it. For example, in FIG. 1, each end ofthe main body 62, the end of the lower arm 64, and the end of the upperarm 66 include a slot to allow the headgear strap to pass through it inuse. FIG. 3 shows the mesh-like rigidizer 360 with upper and lowerconnectors 365, 366 (e.g., overmolded to mesh) with slots for receivingheadgear straps. In FIG. 5, the rear portion of rigidizer 560 mayinclude upper and lower slots for receiving upper and lower rear straps540, 550. FIGS. 6-11 also show one or more slots provided to therigidizer 660 for receiving headgear straps.

In another embodiment, the rigidizer may provide loops to receiveheadgear straps. For example, in FIG. 2, upper and lower ends of therigidizer 260 include connectors 265 that provide a loop for receivingrespective headgear straps. The lower connectors 265 are aligned with aslot in the rigidizer covering so that the lower strap 230 passesthrough the slot positioned at the back of the patient's head, i.e.,lower strap 230 passes through a void in the rigidizer 260.

FIGS. 10-13 show an arrangement wherein the rigidizer and straps providea press stud arrangement. As illustrated, the lower end of the rigidizermay include a strap portion 662 with a plurality of holes 663, and oneend of the lower strap 630 may provide a stud 665 (e.g., overmolded orsonically welded to strap) adapted to be press fit into a selected oneof the holes 663. As shown in FIG. 13, the stud 665 and holes 663 areconfigured to provide a snap fit arrangement. The opposite end of thelower strap 630 may include a Velcro® tab for attachment to the mask.

FIGS. 25A to 25C show a further adjustment mechanism for a top strap4412. A forehead support 5000 may be provided to a mask 10. Foreheadsupport 5000 may allow the top strap to be looped through an aperture5005. As best shown in FIG. 25C, forehead support may be provided with apush tab 5010 that is pre loaded or biased with spring 5025 so as toallow for engagement and disengagement of looped through portion of thetop strap 4412. Gripping portion 5015 may be provided on an oppositeside of the forehead support 5000 to push tab 5010 for the patient tostabilize the mechanism on their forehead. Additional gripping portion5020 may be provided at the end of looped portion of top strap 4412.Additional gripping portion 5020 may also prevent disassembly of thelooped portion by pulling it back through aperture 5005.

FIG. 26 also shows a further alternative method of adjusting bottomstraps 4513, wherein the perforations 6000 may be provided along thelength of the bottom strap 4513 that may allow the patient to tear orcut segments of the bottom strap 4513 off to shorten its length.Perforations 6000 may be weakened regions along the bottom strap 4513,for example thinner cross section, narrower strap width.

Additional Embodiments

FIG. 18 also shows a first strap 3010 with an encapsulated rigidizer3001 that may have bows or bends 4000. Bends 4000 may be provided inselect region(s) of rigidizer 3001 to allow the rigidizer to readilyflex or hinge at the region(s). This may be beneficial for fitting alarger range of patient head sizes. As shown in FIG. 18, bends 4000 maybe positioned so as to allow lower portions of the rigidizer to flexoutwards towards the ears of the patient or inwards towards the centreof the patient's head. Bends 4000 may be weakened regions to achieve asimilar flexibility in the rigidizer 3001. For example, bends 4000 maybe curved portions, portions with a thinned cross section, narrowedportions of the width of the rigidizer 3001. This bending portion maynot be in tension as other parts of the headgear, e.g., the upper andlower headgear straps for direct attachment to the mask system.

FIG. 20 shows a further arrangement wherein the first strap 3010 mayhave an encapsulated rigidizer 3001 (not shown) and may be provided witha top strap 3012 and a bottom strap 3013. Top strap 3012 and bottomstrap 3013 may each be a single length of material that may loop throughor otherwise attach to first strap 3010. Securing means (for example,hook and loop attachment, press studs, adhesive) may be attached at theends of top strap 3012 and bottom strap 3013 to allow for adjustment ofthe length of the straps.

FIG. 21 shows a further arrangement wherein a first strap 4010 (that maybe provided with an encapsulated rigidizer (not shown)) is joined at itslower end by stitching, gluing, welding, or other means. Alternatively,first strap 4010 may be formed of a single circle or loop or material.First strap 4010 may be formed in one piece by ultrasonic die cutting.The circumference of the first strap (measured from the inner edge, oredge that is furthest from the top strap 4012 and bottom strap 4013) maybe about 420-600 mm. Preferably, the circumference may be about 480-540mm. Preferably, the circumference may be about 490-505 mm. Preferablythe circumference may be about 500 mm. With a circumference in theseranges, the headgear may fit the crown region of the head for a largerproportion of the population. Additionally, the rigidizer may avoidcontacting the ears of the patient. Furthermore, the rigidizer may avoidcontacting the lower neck or upper back or spine of the patient.

FIG. 21 also shows top straps 4012 attached to first strap 4010 at join4035. Join 4035 may be stitching, ultrasonic welding, gluing, or anyother joining means, or a combination of means. Top straps 4012 may beprovided with adjustment means 4020 at their free ends, for example hookor loop material, press studs, etc. Bottoms straps 4013 may be attachedto first strap 4010 by join 4035. Join 4035 may be stitching, ultrasonicwelding, gluing, or any other joining means, or a combination of means.Bottom straps 4013 may be provided with adjustment means 4020 at theirfree ends, for example hook or loop material, press studs, etc. In afurther alternative embodiment, first strap 4010, top straps 4012, andbottom straps 4013 may be formed in one piece. The single component maybe formed by manually rolling an ultrasonic welder around the perimeterof the component. In an embodiment, this method may provide some edgesthat are not consistent as this method relies on manual control of theprocess. The single component may be constructed by ultrasonic diecutting. This may be advantageous as each headgear may be more uniformor consistent as the process can be more strictly controlled.Alternative methods of construction are also possible, includingultrasonic welding and Computer Numerical Control (“CNC”).

FIG. 22 shows a rear view of a first strap 4110 (that may be providedwith an encapsulated rigidizer (not externally visible in FIG. 22)) inits in use position. Angle a shows the angle of alignment of the bottomstraps 4113 with respect to a horizontal plane. Bottom straps 4113 arepreferably angled or deflected downward by angle a to guide the bottomstraps below the ears of the patient. Angle a may be greater than 0°.Angle a may be 0°-90°. Preferably, angle a may be about 10°-30°.Preferably, angle a may be about 15°-20°. Angle a may be about 11°.First strap 4110 may also be provided with a top strap 4112 that may beelastic. Bottom straps 4113 may be attached to first strap 4110 by joins4134, 4135.

FIG. 22 also shows length L, which is the width of the lower portion ofthe first strap nearest join 4130. Preferably, length L may be less thanabout 60 mm to avoid contact with the neck or upper back or spine of thepatient. Preferably, length L may be about 30-50 mm.

As shown in FIG. 22, the upper region of the headgear defined by thefirst strap 4110 is arched to engage the crown of the patient's head. Inuse, the first strap 4110 extends in a horizontal plane 4115 through thewidest portion of the arched region so as to lie flat on the crown ofthe patient's head. The lower portions or sides of the first strap 4110extend through a vertical plane (parallel to vertical axis 4116) at thewidest portions of the lower portions or sides of the first strap. Thisconfiguration allows the region of the headgear including the firststrap 4110 to lie flat on the back of the patient's head. In the casewhere the first strap 4110 is provided with an encapsulated rigidizer,the configuration of the first strap 4110 in combination with therigidizer provides the headgear with a 3D shape.

FIG. 23 shows a further arrangement wherein first strap 4210 (that maybe provided with an encapsulated rigidizer (not shown)) may be attachedto top strap 4212 by joins 4235. Joins 4235 are shown as ultrasonicwelds, however may be any other reasonable method of attaching the topstrap 4212 to first strap 4210. Top strap 4212 may be elastic, or anyother suitable material. Bottom strap 4213 may be passed through loops4235 on first strap 4210. Bottom strap 4213 may be made from elastic orany other suitable material. Bottom strap 4213 may also be adjustable byproviding ladder locks 4220 on its ends. By sliding ladder locks 4220along the length of bottom strap 4213, the length of the strap maychange.

FIG. 23 further shows rigidizer lower portion 4250 that may be curved insuch a way so as to avoid contacting the back of the patient's ear whenin use. The curvature of this lower portion 4250 on FIG. 20 is such thatthe first strap 4210 follows a similar radius of curvature along itslength. As shown in FIG. 23, the radius of curvature of lower portion4250 is different to that of the upper portion 4260. Lower portion 4250may have a radius of curvature less than that of upper portion 4260. Theshape of first strap 4210 may be similar to the rigidizer 4201 (notexternally visible in FIG. 23) encapsulated within it.

FIG. 27 shows rigidizer 4201 where the lower portion 4251 may have aradius of curvature less than that of upper portion 4261. Alternatively,a bend 4200 may be provided to rigidizer 4201 so that lower portion 4251is positioned further in towards the centre of the patient's headthereby avoiding contact with the back of the patient's ears in use.

FIG. 28 shows rigidizer 4201 nested or positioned multiple times on asingle piece of base material to demonstrate the ability of therigidizer's shape to be manufactured and wherein multiple rigidizers4201 are produced with minimal wasted base material.

FIG. 29 shows a flattened first strap 4210 with the encapsulatedrigidizer 4201 (as delineated by dashed lines) to demonstrate thesimilar curvature or general arcuate shape of the two parts when formedor joined together. In this embodiment, either end 4280 of rigidizer4201 may preferably: have a maximum length no greater the furthest pointof the end 4211 of first strap 4210; and have a preferred minimum lengthof no less than the distance required to prevent or limit the end 4211from distorting or bending, when a further strap is connected to end4211 and when the headgear is tightened on a patient's head. Thisfeature may also avoid rigidizer 4201 causing discomfort or irritationon the patient's neck or upper back/spine.

FIG. 30 shows a further embodiment of the present technology, whererigidizer 4601 may be encapsulated within a first strap 4610. Rigidizer4601 may extend only across the centre portion of first strap 4610, suchthat when in use, is only located at approximately the top, upper halfof the patient's head. This may increase comfort while maintaining thestability of previous embodiments. Additionally, the reduced lengthrigidizer 4601 may increase the comfort of this embodiment and yet moreallow the strap to retain a shape and configuration that may allow auser or patient to quickly fit or wear the headgear. One advantage ofrigidizer being mounted within the headgear is the part of the headgearthat engages the rear portion of the patient's head includes enoughsupport in the form of rigidity to maintain its basic shape and toprevent or limit distortion whilst the patient is donning the headgear.

FIG. 24 shows a further embodiment where top strap 4312 and bottom strap4313 may be adjustable with ladder locks 4320. Top strap 4312 and bottomstrap 4313 may be attached to a first strap 4310 with an encapsulatedrigidizer (not shown).

In an embodiment, one or more aspects of the headgear may be structuredto prevent or at least reduce the chances of headgear riding up thepatient's head and causing the straps to abut or touch underneath thepatient's ears in use.

For example, as shown in FIG. 36, the position of the crown strap 7360may be moved rearwardly (i.e., change the angle of the crown strap) toreduce the chances of headgear ride up. The original position of thecrown strap 7360 is indicated in FIG. 36 by the solid line. The originalposition of the crown strap 7360 may be vertical direction or in thedirection of the frontal plane of the body. In an example, the crownstrap 7360 may be moved back by up to 40° from the position shown inFIG. 36, e.g., moved back 15° as indicated by α1, 20° as indicated byα2, and 40° as indicated by α3. Also, moving the crown strap rearwardlyimproves cradling in the crown region of the patient's head to enhancesupport, e.g., so crown strap is not too loose on the top of thepatient's head. Furthermore the strap may include a curvature such as aJ-shape, or a “dog leg” shape to direct a headgear vector around an ear,for example having a radius of approximately 50 mm to 70 mm, morepreferably about 55 mm to about 65 mm, as shown in FIG. 36. FIG. 37illustrates how the crown strap 7360 helps to maintain sufficientspacing of the lower strap 7364 from the patient's ear.

In another example, as shown in FIGS. 38 and 39, the rigidizer 7460 maybe extended to enhance support along the bottom strap along the bottomof the neck. In addition, the length of the top strap 7466 may beextended to enhance the positioning of the crown strap. Preferably, therigidizer 7460 may support or position the lower straps of the headgearunderneath or out of contact with the patient's ears. Also, therigidizer 7460 may prevent the headgear from riding up or translatingvertically upwards on the patient's head, by securing the headgear atthe occiput and/or neck of the patient. The inextensibility of therigidizer 7460 also prevents the crown strap 7462 from being stretchedinto impinging on the patient's ears. The crown strap 7462 secures theheadgear in position so that the headgear does not slide forward oraround the patient's head. The bottom and top straps 7464, 7466 may bemore elastic or extensible than the crown strap 7462.

In an example, as shown in FIGS. 38 and 39, the diameter d of the crownstrap 7462 preferably may be about 500 mm, and the top strap 7466 may beoriented at an angle α1 of about 90° with respect to the crown strap.The lower strap 7464 may be oriented at an angle α2 of about 15-30°,e.g., 20°, down from horizontal. In a further example, the diameter d ofthe crown strap 7462 may be about 440 mm to about 600 mm. In a furtherexample, the diameter d of the crown strap 7462 may be about 500 mm toabout 600 mm. In a further example, the diameter d of the crown strap7462 may be about 550 mm to about 600 mm. In a further example, thediameter d of the crown strap 7462 may be about 440 mm to about 550 mm.In a further example, the diameter d of the crown strap 7462 may beabout 440 mm to about 500 mm. The diameter d defines a loop of a backportion of the headgear that circumscribes the rear of the patient'shead such that little, or none, of the headgear is between the patient'shead and the pillow or bed when the patient is lying on his/her back.

1.2.3 Rigidizer/Strap Adjustment

In an embodiment, adjustment of the rigidizers and headgear straps maybe provided by hook and loop material (e.g., Velcro®), elastic, pressstuds, etc).

For example, in FIGS. 1-2 and 6-10, one or both ends of the straps 20,30, 220, 230, 620, 630 include a Velcro® tab structured to engage theremainder of the strap to secure the strap in place and allow adjustment(e.g., with respect to the rigidizer and/or mask).

In FIGS. 1, 4, and 5, one or more straps 40, 440, 450, 540, 550 are inthe form of an elastic component to allow adjustment.

Elastic provided to a top strap of a headgear (for example, top strap3012 in FIG. 20) may be 250-450 mm in length. Preferably, elastic topstrap may be about 320-400 mm. Preferably, elastic top strap may requireno more than 10 N of force to stretch the elastic 100 mm from itsoriginal length. Preferably, elastic top strap may require no more than6 N of force to stretch the elastic 100 mm from its original length.Preferably, elastic top strap may require no more than 4 N of force tostretch the elastic 100 mm from its original length. Preferably, elastictop strap may require no more than 3 N of force to stretch the elastic100 mm from its original length. This may ensure the headgear iscomfortable for a range of patient's head sizes.

In FIGS. 10-13, one or more straps include a press stud arrangement asdescribed above to allow adjustment.

1.2.4 Rigidizer Material

The rigidizer may have composite construction with two or more materials(rigid or semi-rigid material with a covering constructed of a softer,patient contacting material), may be constructed of alternative fabricor polymeric materials (3D weave, knit, non-wovens, laminates), and maybe manufactured in alternative manners.

For example, the rigidizer may be made from any flexible, conformingmaterial such as nylon, polypropylene, polycarbonate, polystyrene,polyethylene, thermoplastic elastomer (TPE), thermoplastic urethane(TPU), silicone, polyester, etc (e.g., see FIG. 1). In FIG. 3, therigidizer 360 is a 3D weave/knit with overlocked edges.

The rigidizer may also be constructed by thickening or treating a fabricsuch that it is stiffer or impedes the stretch of the material. Forexample, the fabric may be printed on such that the ink from the printrestrains or reduces the capacity of the fabric to stretch.Additionally, the fabric may be stitched in selected regions to stiffenit. Also, the fabric may be ultrasonically welded in selected regions tostiffen it.

The rigidizer may be constructed from a non-woven material, for examplenetting, such that it is resistant to stretching in at least onedirection.

The rigidizer may alternatively be formed from a woven material, wherethe grain of the material is aligned such that the fabric may notstretch in the lateral direction (when positioned on the patient's head)to secure and anchor the headgear in position on the patient's head.

The rigidizer may also be formed by a layer of additional material suchas silicone, polyurethane or other tacky material, that may be appliedto a fabric strap to reinforce the strap. Silicone beading or polymericover molding may also be used.

The rigidizer may be 0.1 mm to 10 mm thick. Depending on theconstruction material of the rigidizer, the rigidizer may be preferablybetween 0.5 mm and 5 mm thick. Generally, the thinner rigidizers mayresult in more comfortable headgear for the patients. Thicker rigidizersmay be the more dimensionally stable or rigid.

The rigidizer may be 1 mm to 30 mm wide. Preferably, the rigidizer maybe 5-20 mm wide. Preferably, the rigidizer in some of the embodimentsdescribed herein may be 10 mm wide. To increase flexibility along thelength of the rigidizer, the material may be thinner in its width thanheight, or narrower in its width for a thicker material.

In another embodiment, the rigidizer may have the same width or a widthless than a fabric backing material. The fabric backing material is incontact with the patient's head in use. This is to increase the comfortof the headgear system in use.

In a further embodiment, the rigidizer may be encapsulated within asuitable fabric material to improve patient comfort and wearability.

The rigidizer may be overmolded (e.g., TPE overmolded with a softermaterial (e.g., see FIG. 10)) or formed separately and then a sock ofpatient contacting material (e.g., Breath-O-Prene™) may be wrapped orslid over the rigidizer (e.g., see FIGS. 2, 6, and 9). In alternativeembodiments, the patient contacting material may be provided to therigidizer by adhesive, ultra sonic welding, sewing, hook and loopmaterial, and/or stud connectors. In an embodiment, the patientcontacting material may only be on the patient contacting side of therigidizer to reduce bulk and cost of headgear.

The resilient structure of the rigidizer may also improve the anchoringof the straps to it and may prevent the straps from tearing or rippingthrough the rigidizer under conditions of normal use by a patient.

FIGS. 14A to 14G are cross-sectional views showing alternative rigidizerconfigurations. As shown in FIG. 14A, the rigidizer may include a diecut sheet material 780 that is covered in fabric 781, e.g., two piecesof fabric joined by stitching or gluing. Preferably, the joint of thefabric is within the strap, such that the joint is not able to contactthe patient's face in use. This may be achieved by sewing the strapinside out and returning it to its intended orientation so that thestitching is within the pocket of the fabric. The fabric provides asofter material for contacting the patient's face in use. The softermaterial may also be suitable for the selective attachment of Velcro™tabs. The fabric on the patient contacting side may be the same as thefabric on the non-patient contacting side. The fabric on the patientcontacting side may preferably have the same weave as the fabric on thenon-patient contacting side, such that the stretch characteristics ofthe straps are approximately equal on both sides. Also, it is preferredthat the fabric on the patient contacting side have the same heatshrinkage characteristics as the non-patient contacting side. This is toprevent the headgear deforming unevenly when thermoformed or otherwiseprocessed or exposed to heat. The fabric on the patient contacting sidemay be a different fabric to the non-patient contacting side, such thatthe fabric on the patient contacting side is more comfortable than thenon-patient contacting side.

As shown in FIG. 14B, the rigidizer may include a die cut sheet material880 that is overmolded with a soft polymeric material 881, e.g., TPE,TPU. The polymeric material provides a softer material for contactingthe patient's face in use.

As shown in FIG. 14C, the rigidizer may include a semi-rigid moldedcomponent 980 that is covered in fabric 981, e.g., two pieces of fabricjoined by stitching.

As shown in FIG. 14D, the rigidizer may include a semi-rigid moldedcomponent 1080 that is attached (e.g., welded, glued, overmolded) to afabric composite material 1081 (e.g., Breath-O-Prene™ material orsimilar). The fabric composite material provides a softer material forcontacting the patient's face in use.

As shown in FIG. 14E, the rigidizer may include a semi-rigid moldedcomponent 1180 that is overmolded with a soft polymeric material 1181,e.g., TPE, TPU. The polymeric material provides a softer material forcontacting the patient's face in use.

As shown in FIG. 14F, the rigidizer may include a soft molded component1280 molded with a soft polymeric material, e.g., TPE, TPU. In anembodiment, the molded component may be provided with soft touch orflock coatings.

As shown in FIG. 14G, the rigidizer may include a fabric outer layer1381 thermoformed and attached to a rigidizer 1380. The rigidizer may bea die cut sheet material. Alternatively, the rigidizer could be a moldedpart, machined part, or otherwise formed part. The fabric outer layersmay be heat sealed together, stitched, ultrasonically cut, CNC knifecut, or otherwise joined. As illustrated, the fabric outer layer 1381 isjoined at approximately the center or middle of the edge. Preferably,the joint is at the center or close to the center of the side of theheadgear. Alternatively, the joint may be positioned away from thepatient's face when in use. It is also possible to position the jointadjacent or close to the patient's face in use. Preferably, a layer offoam or other conformable material may be positioned around or about therigidizer 1380. The foam may preferably extend to the lateral,horizontal edges of the rigidizer 1380 so as to prevent the ends of therigidizer abutting the patient's face and causing discomfort or facialmarking. For example, FIG. 14H illustrates a rigidizer 1480 with fabricouter layers 1481 and a foam layer 1482 provided along at least aportion of the rigidizer 1480. As illustrated, the foam layer 1482positions the joints 1483 away from the patient's face when in use.

In an embodiment, the headgear strap may be thermoformed and then edgesof the strap may be ultrasonically cut. The thermoformed andultrasonically cut strap provides rounded edges 7081 (as shown in FIG.31) which provides substantially reduced facial marking in use. Inaddition, the thermoformed and ultrasonically cut edges are softer andless abrasive, which provides a more comfortable feel on the patient'sface in use, e.g., more comfortable feel around the patient's ears.

In a further embodiment, at least a portion of the headgear may beconstructed from a spacer fabric, where the edges of the spacer fabricmay be ultra sonically welded. This may cause the edges of the spacerfabric to be rounded, thereby reducing facial marking and increasingcomfort for the patient.

In an alternative embodiment, the fabric outer layers may be attachedtogether by adhesive. For example, as shown in FIG. 14I, a first layerof fabric 1581(1) may have wings 1585 positioned at one or both ends.Adhesive 1586 (e.g., glue) may be positioned on ends of a second layerof fabric 1581(2), such that the wings 1585 can be folded onto theadhesive to seal the inner portions of the headgear within the fabriclayers. As illustrated, the inner portions of the headgear may include aconformable material such as foam 1582, or a rigidizer 1580, or acombination of the two. Alternative internal components may includeother elements disclosed herein, such as 3D weaves. It should further beappreciated that the adhesive and wings may be positioned in alternativearrangements, such as the adhesive positioned on the wings, or the wingspositioned on the second layer of fabric. It is further possible for thefirst and second layers of fabric to be a single, continuous piece offabric that is sealed at one end by a wing and adhesive arrangement. Forexample, FIG. 14J shows a single piece of fabric 1681 including a wing1685 at one end that is adapted to be folded onto adhesive 1686 (e.g.,glue) at the other end. As illustrated, the inner portions of theheadgear include a conformable material such as foam 1682 and arigidizer 1680.

Preferably, the edges of the headgear are completely closed, that is,the interior components of the headgear (such as the rigidizer andconformable material) are completely contained within the fabric outerlayers. This is to avoid hair tangling in the internal components ordiscomfort due to contact with the interior elements. In addition, itmay be easier to maintain the cleanliness and durability of the systemif the internal components are completely encapsulated or containedwithin the fabric layers.

Preferably, the edges where the fabric layers meet one another aresealed or otherwise hidden to avoid the fabrics from parting or becomingdislodged. This arrangement may also be preferable for creating arounded continuous edge. See FIG. 14A for example.

In an embodiment, one or more aspects of the headgear strap may bestructured to enhance comfort of the crown strap (i.e., the strapadapted to pass over the top of the patient's head in use). For example,the rigidizer may be relatively thin, e.g., less than 1 mm such as 0.5mm or 0.8 mm. In another example, the strap may include a nylonrigidizer enclosed in foam. In such embodiment, the density of the foammay be increased to improve comfort and reduce chances of feeling thenylon rigidizer. Alternatively, the thickness of the foam may beutilized to alter the softness or roundness of the edge of the headgear.For example, thicker layers of foam are more likely to produce roundercorners than thinner layers of foam. In a further embodiment, the foammay begin at one thickness, and be compressed to another thicknessduring processing. The first thickness of the foam may be 5 to 30 mm.Preferably, the first thickness may be 7 to 12 mm. Alternatively, thefirst foam thickness may be 10 to 20 mm. The second foam thickness maybe 0.1 to 10 mm. Preferably, the second foam thickness may be 2 to 5 mm.The second foam thickness may alternatively be 3 to 7 mm.

In another example, a non-woven material (e.g., such as that shown inFIG. 32) may be used for the crown strap because it may be more rigid orless flexible than a woven material, e.g., business shirt collarstiffener is a non-woven material.

In another example, the rigid component may be removed from the crownstrap and as an alternative a fabric crown strap 7181 may be heatpressed or embossed with a foam inner 7180 to melt the foam and create astiffened region (see FIGS. 33 and 34). In an example, a thermoformedrib may be formed by compressing the foam by about 80%.

In another example, multiple ribs 7280 may be embossed into therigidizer to reduce visual bulk and add rigidity, as shown in FIG. 35.

Also, the rigidizer may include embossed ribs or other features toencourage flex or control movement of the headgear in specific regions.In addition, embossing may be used to stamp on a branding logo.

In an example, the headgear strap may include two layers of foam.However, other suitable configurations are possible, e.g., 1, 2, 3, ormore layers of foam. In an embodiment, foam on the patient contactingside may be less dense or have a lower hardness than foam on non-patientcontacting side. It is also possible to have more than one layer of foamand more than one rigidizer component. Alternatively, the headgear maycomprise more than one rigidizer and a single layer of foam.

In an example, non-woven material may be inserted in-between additionalfoam or fabric layers in place of a nylon rigidizer.

In an embodiment, the materials and/or headgear configuration may beselected to reduce costs.

2.0 Manufacturing

Preferably, the method of manufacturing the headgear may reduce costs bymaximizing volume and eliminating material wastage. For example,components may be shaped such that they can be nested closely on thebulk material such that when die cut into individual components, wasteis reduced waste thereby reducing cost.

FIGS. 41 and 42 show exemplary processing steps for creating headgear asdescribed. Alternative manufacturing steps are also possible.

For example, FIG. 41 shows an exemplary process for creating rigidizedheadgear. This exemplary process includes material lamination (foam andfabric joined together by a lamination process), thermoforming (foam andfabric lamination placed in tool, pre-shaped rigidizer placed in thetool on top of first lamination layer, a second foam and fabriclamination layer placed on top of rigidizer; tool closed, heat applied,laminations permanently join around tool faces) ultrasonic die cut(thermoformed sheet placed on die cutting machine, ultrasonic weldertravels around perimeter of headgear), and joining (lower portion ofheadgear crown cap joined together, headgear straps attached to crowncap). In one process, the lamination step may be omitted. In anotherprocess the thermoforming and ultrasonic cutting may be completed in onestep.

FIG. 42 shows an exemplary process for creating non-rigidized headgear.This exemplary process includes material lamination (foam and fabricjoined together by a lamination process), thermoforming (foam and fabriclamination placed in tool; tool closed, heat applied, laminationspermanently join around tool faces), ultrasonic die cut (thermoformedsheet placed on die cutting machine, ultrasonic welder travels aroundperimeter of headgear), and sewing (lower portion of headgear crown capjoined together, headgear straps attached to rigidizer).

As illustrated in FIG. 16A, a headgear component 660 in accordance withthe present technology may be arranged for die cutting from a sheet. Inthe example of FIG. 16A, twelve headgear components 660 may be cut froma single sheet 2500 of fabric material. The headgear components 660shown in FIG. 16A may be joined to a set of relatively straight strapsthat may also be efficiently nested (not shown), the combination makinga complete headgear assembly. By way of contrast to a prior artconfiguration shown in FIG. 16B, only three headgear assemblies 2600 maybe cut from a similarly sized sheet 2500 of a different design as shownin FIG. 16B. The manufacturing yield of FIG. 16B is approximately 11.5headgears per meters². For purposes of this specification, “highmanufacturing yield” is defined as any and all manufacturing yieldshigher than 11.5 headgears per meters².

In contrast to other prior art headgear configurations, such as theResMed Quattro™ headgear, embodiments shown are constructed frommultiple components that when separate, are simple geometric shapes thatcan be nested easily. For example, in the embodiment shown in FIG. 6,the upper headgear strap 620 and lower headgear strap 630 aresubstantially straight, rectangular components that could be nested andcut from a bulk piece of material without waste. Alternatively, upperheadgear strap 620 and lower headgear strap 630 could be formed fromwoven materials and cut to length without waste. Rigidizer 660 may beformed from a flat piece, such as that shown in FIG. 15. In such aconfiguration, multiple rigidizers could be formed from a single bulksheet of the rigidizer material with minimal waste as the rigidizers canbe nested close together as shown in FIG. 16A. The Rigidizer 660 has agenerally arcuate shape, but could be regarded by a person skilled inthe art as a relatively simple geometric shape.

This is in contrast with prior art headgear such as the ResMed Quattro™headgear, as such a shape can be nested closely but waste is generateddue to the general shape of the headgear (i.e., apertures or holes inthe headgear that must be stamped out).

A further embodiment is depicted in FIGS. 17-20. FIG. 20 depicts anassembled headgear 3015 for use attaching medical equipment to the headof a patient. In this embodiment, the preferred medical equipment is themask of a CPAP machine.

The depicted headgear 3015 is adapted to mount a face mask on the faceof a patient. The headgear 3015 comprises first 3010, second 3012, andthird 3013 straps. The second 3012 and third 3013 straps are attached tothe first strap 3010 by attachment means, which comprises a series orplurality of holes or apertures in the first strap 3010 adapted toreceive the other straps. The second 3012 and third 3013 straps may befixed or connected to the first strap 3010 by the use of one or moreVelcro™ tabs adapted to loop back onto the original strap and attach tothe preferably soft fabric material on the outer surface of the straps.Preferably, the Velcro™ tabs and the soft fabric used in the strapscould selectively engage each other in “hook and loop” attachment commonto the use of Velcro™.

The first strap 3010 comprises a construction shown in FIG. 17 and FIG.18. A rigid or semi-rigid layer 3001 of resilient material isencapsulated between a first 3004 and a second layer 3002 of soft fabricmaterial. Preferably, the soft fabric is adapted to be biocompatible, asin use, the layers 3002 and 3004 may contact the skin layer of thepatient. Biocompatibility and softness may both reduce skin irritationto the patient.

Encapsulated between the rigid layer 3001 and the first soft fabriclayer 3004 is a layer of cushioning 3003. Preferably, this cushioninglayer 3003 is constructed a soft foam like material. In use, the firststrap 3010 is preferably adapted to contact the skin layer of patient bycontact with the first soft fabric layer 3004. The layered configurationof the first strap 3010 as depicted in FIG. 17 may only be required toextend along a portion of one of the straps to function correctly asdisclosed in this embodiment.

Preferably, the layers of the first strap 3010 may be attached to eachother by vulcanization or gluing. Additionally, the first fabric layer3004 and second fabric layer 3002 are not required to be of the same oridentical material and may be substitute to improve the aestheticappearance of the headgear 3015.

In this embodiment, the second strap 3012 and third strap 3013 may beentirely constructed of soft fabric material to improve comfort.However, other strap configurations are possible.

The rigid layer 3001 or rigidizer may preferably be constructed ofpolycarbonate, Lexan™ or similar resilient material of about a thicknessof 1-2 mm. The soft fabric material may be Breath-O-Prene™ or other softfabric material including but not limited to nylon or Spandex™.

Preferably, the first strap 3010 may function as a rigidizer within theoverall headgear assembly or configuration 3015 as shown in FIG. 20. Oneadvantage with including a rigidizer within this construction is that itmay allow for equalized distribution of pressure around the patient'shead, particularly, when mounted in the configuration shown in FIG. 20.This embodiment may increase patient comfort by the rigidizer beingmounted around or on the posterior of the patient's head.

Of further advantage in this embodiment, the construction of the strapsmay be optimized to reduce wastage. Previously, straps of headgear wereconstructed by cutting the entire headgear from a single bulk piece ofmaterial, which created a relatively large amount of waste material.FIG. 19 depicts a plurality of straps to be cut out of a bulk piece ofmanufacturing material. As depicted, the second layer 3002 of softfabric material of the first strap 3010 is shown within a bulk sheet3011 of material. In this example, the wastage is limited and minimizedby nesting each of the component straps closely together on the samebulk sheet 3011.

In a further embodiment, an inner layer of foam may be molded, such thata skinned foam is formed in the shape of the headgear. Alternatively,any foam (skinned, unskinned or partially skinned) may first be formedor otherwise shaped to the shape of the headgear. Fabric may then belaminated onto the foam layer.

In a further alternative embodiment, a fabric or textile may be placedwithin a mold and a polymer or other such moldable material may beinjected onto the fabric to the desired shape of the headgear.

In a further embodiment, the fabric outer layer may be filled with gel,air and/or other gas. The gas may be selectively filled in pockets withvarying volumes in each pocket to influence the rigidity or supportprovided by that section of the headgear. The fabric outer layer mayneed to be gas tight, so may for example be laminated with animpermeable polymer layer.

In a further alternative embodiment, the outer layer of fabric may beformed around or over two cords of material. The cords of material areintended to create a round edge at the sides of the material. Forexample, FIG. 43 shows a cross section through a proposed headgear orportion thereof, wherein the cords 1785 provided within the outer fabriclayer 1781 are rounded sections of material. The cords may be providedto both sides (as shown) or may be provided to just one side of theheadgear strap. The cords may be constructed of foam, gel, polymer, orany other conformable material. The cords may have alternative shapes,for example they may have an ovoid or elliptical cross section. Thecords are further shown as being separate (that is, not joined togetherthrough the center portion of the headgear section), however it ispossible for the cords to be connected to one another.

It should also be appreciated that the foam outer layer may also beconstructed of a single piece of material that is continuously weaved tomake a tube of fabric.

It should be appreciated that while this technology has been describedin relation to a headgear for a mask system, this technology may beapplicable to other portions of the mask system, such as forehead pads,mask cushions, comfort pads, tube wraps, comfort socks, chin straps,mask frames or any other suitable portion of the mask system.

It is possible for a quick release mechanism to be attached to theheadgear, for example a selectively releasable portion at the rear ofthe headgear. This may include a hook and loop material connection witha pull cord. Alternatively, the quick release mechanism may be a clip orany other mechanism to allow the patient to remove the mask system in anemergency.

In a further embodiment, it is possible for a tube mounting component tothe attachable or formed with the headgear. For example, a strap forwrapping around a tube may be provided to the headgear, that may beattached to the tube by a hook and loop connection. Alternatively, clipsor rings may be attached or formed with the headgear for engagement witha tube.

The rigidizer may also be formed from a selectively adjustable shapechangeable material. For example, the rigidizer may be formed from ametal such that the patient can adapt the shape of the headgear to theirdesired position. It may also be possible to form the rigidizer from aheat deformable material, such that the headgear may be heated andpositioned on the patient's head, and then taking on the form or shapeof the patient's head. When the headgear is cooled, it may retain thisshape. The rigidizer may also be formed of a malleable material, such asnitinol, that is able to be shaped.

The headgear may also be provided with pockets or gaps for insertingadditional material or removing material. This may be provided so thatthe patient can alter and adapt the stiffness or comfort of the headgearin specific regions. For example, a pocket or space may be provided tothe rear of the headgear so that the patient can add padding orconformable materials to this portion of the headgear.

In a further embodiment, the headgear may be provided with socks orwraps of padded or soft material to provide the patient with additionalcomfort should they require it. The socks or wraps may be selectivelyattachable to the headgear straps, for example by clipping, hook andloop material, pulling over or any other reasonable attachment method.

It may also be possible to provide the headgear with sensors fordiagnosing or monitoring the patient.

In an alternative embodiment, the above described rigidizer may bereplaced or supplemented with one or more elements possessingsubstantial inextensibility and/or resilience. For example, instead ofusing the above described rigidizer, stitching or embossing may be usedto create a substantially inextensible structure. Furthermore, anon-rigid spring structure may provide resilience.

While the technology has been described in connection with what arepresently considered to be the most practical and preferred embodiments,it is to be understood that the invention is not to be limited to thedisclosed embodiments, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andscope of the invention. Also, the various embodiments described abovemay be implemented in conjunction with other embodiments, e.g., aspectsof one embodiment may be combined with aspects of another embodiment torealize yet other embodiments. Further, each independent feature orcomponent of any given assembly may constitute an additional embodiment.In addition, while the invention has particular application to patientswho suffer from OSA, it is to be appreciated that patients who sufferfrom other illnesses (e.g., congestive heart failure, diabetes, morbidobesity, stroke, bariatric surgery, etc.) can derive benefit from theabove teachings. Moreover, the above teachings have applicability withpatients and non-patients alike in non-medical applications.

What is claimed is:
 1. A respiratory mask assembly for treatment ofsleep disordered breathing in a patient, comprising: a mask; a headgearsystem including a plurality of straps cooperative with the mask andpermitting adjustable fit of the mask, the plurality of strapscomprising: a rear portion having a closed rear loop to engage andcircumscribe a back of the patient's head; a first upper strap and asecond upper strap each attached to the rear loop via stitching, thefirst upper strap attached at a first join, the second upper strapattached at a second join, a first rear loop edge of the rear loopabutting a first upper strap edge of the first upper strap at the firstjoin, a second rear loop edge of the rear loop abutting an edge of thesecond upper strap at the second join; wherein the first upper strapcomprises a first upper patient-contacting fabric material layer and afirst upper outwardly facing loop material layer, the second upper strapcomprises a second upper patient-contacting fabric material layer and asecond upper outwardly facing loop material layer; a first lower strapand second lower strap each attached to the rear portion via stitching,the first lower strap attached at a first lower join, the second lowerstrap attached at a second lower join, a first rear portion edge of therear portion abutting a first lower strap edge of the first lower strapat the first lower join, a second rear portion edge of the rear portionabutting a second lower strap edge of the second lower strap at thesecond lower join; wherein the first lower strap comprises a first lowerpatient-contacting fabric material layer and a first lower outwardlyfacing loop material layer, the second lower strap comprises a secondlower patient-contacting fabric material layer and a second loweroutwardly facing loop material layer; wherein the first lower strap andthe second lower strap are each configured to extend below the patient'sears in use; wherein a first upper hook portion is located proximate afree end of the first upper strap, a second upper hook portion islocated proximate a free end of the second upper strap, a first lowerhook portion is located proximate a free end of the first lower strap,and a second lower hook portion is located proximate a free end of thesecond lower strap; wherein the first upper strap, the second upperstrap, first lower strap, and the second lower strap arelength-adjustable via a hook and loop connection; wherein the mask issecured to the patient's head with only four points of attachmentincluding the first upper strap, the second upper strap, the first lowerstrap and the second lower strap; wherein at least a portion of the rearloop is constructed from a laminate having at least a first fabric layerand a second fabric layer, the first fabric layer being constructed andarranged to be located on a non-patient-contacting side in use and thesecond fabric layer being constructed and arranged as apatient-contacting layer, and further wherein the first fabric layer andthe second fabric layer are joined at a first longitudinal edge jointand a second longitudinal edge joint; wherein the first fabric layer andthe second fabric layer directly contact one another along each saidfirst longitudinal edge joint and second longitudinal edge joint;wherein the first fabric layer is formed of a first fabric material thathas different properties than a second fabric material of the secondfabric layer; wherein the laminate has a first rounded lateral edge anda second rounded lateral edge when viewed in cross section; wherein thefirst longitudinal edge joint is positioned at approximately a center ormiddle of the first rounded lateral edge when viewed in cross sectionand the second longitudinal edge joint is positioned at approximately acenter or middle of the second rounded lateral edge when viewed in crosssection; and wherein the first longitudinal edge joint and the secondlongitudinal edge joint are selected from the group consisting of: anultrasonic weld joint, a heat sealed joint, and a computer numericalcontrolled knife joint.
 2. The respiratory mask assembly of claim 1,wherein the rear portion is constructed and arranged to remainrelatively fixed in position on the patient's head in use; wherein thefirst upper strap has a first upper length spanning between the firstjoin and the first upper hook portion, the second upper strap has asecond upper length spanning between the second join and the secondupper hook portion, and the first lower strap has a first lower lengthspanning between the first lower join and the first lower hook portion,the second lower strap has a second lower length spanning between thesecond lower join and the second lower hook portion; wherein said firstupper length is relatively more extensible than the first lower length,and the second upper length is relatively more extensible than thesecond lower length; wherein the rear portion includes a base portion, afirst elongated body attached to the base portion, a second elongatedbody attached to the base portion, and a top strap that extends betweenthe first elongated body and the second elongated body, wherein aportion of the base portion, the first elongated body, the secondelongated body, and the top strap form the rear loop; wherein the topstrap is configured to extend along the patient's parietal bones;wherein the top strap is elastic; wherein the first elongated body andthe second elongated body each resiliently return to a predeterminedshape when not in use; wherein the first upper strap, the second upperstrap, the first lower strap, and the second lower strap are configuredto removably associate the rear loop with the mask; wherein the rearportion includes a first upper arm extending transverse from the firstelongated body and a second upper arm extending transverse from thesecond elongated body, wherein the first upper strap removablyassociates the mask to the first upper arm, and the second upper strapremovably associates the mask to the second upper arm; and wherein saidfirst lower strap and second lower strap each attach with the mask viaclips.
 3. The respiratory mask assembly of claim 2, wherein the rearloop is arched such that in use an upper portion of the rear loopextends along a first plane such that the upper portion lies flat on acrown of the patient's head, and wherein a lower portion of the rearloop extends along a second plane such that the lower portion of therear loop lies flat on a back of the patient's head, wherein the firstplane is substantially orthogonal to the second plane; wherein the firstelongated body and the second elongated body each comprise a rigidizerbetween the first fabric layer and the second fabric layer, wherein therigidizer is formed of a material selected from the group consisting of:nylon, polypropylene, polycarbonate, polystyrene, polyethylene,thermoplastic elastomer, thermoplastic urethane, silicone, andpolyester; wherein the first elongated body includes a first thickenedportion, and the second elongated body includes a second thickenedportion, wherein the first thickened portion assists in maintaining ashape of the first elongated body and the second thickened portionassists in maintaining a shape of the second elongated body; wherein therigidizer is between 0.5 mm and 5 mm thick; wherein the rigidizer hasthe same width as the first fabric layer and second fabric layer;wherein stretch characteristics are approximately equal on both sides ofsaid first upper strap and second upper strap and said first lower strapand second lower strap; wherein at least a portion of the rear loop isthicker than the said first upper strap and second upper strap, and saidfirst lower strap and second lower strap; wherein the first upper strapand the second upper strap each extend downwardly from the rear looptoward the mask; wherein, in use, said first upper strap and secondupper strap each associate with the mask at a location below thepatient's eyes; wherein said first lower strap and second lower strapeach attach to the base portion; wherein mutual edges of the first upperpatient-contacting fabric material layer and the first upper outwardlyfacing loop material layer form a first upper strap join positioned, asseen in cross section at a first upper lateral edge of the first upperstrap; wherein mutual edges of the second upper patient-contactingfabric material layer and the second upper outwardly facing loopmaterial layer form a second upper strap join positioned, as seen incross section at a second upper lateral edge of the second upper strap;wherein mutual edges of the first lower patient-contacting fabricmaterial layer and the first lower outwardly facing loop material layerform a first lower strap join positioned, as seen in cross section at afirst lower lateral edge of the first lower strap; wherein mutual edgesof the second lower patient-contacting fabric material layer and thesecond lower outwardly facing loop material layer form a second lowerstrap join positioned, as seen in cross section at a second lowerlateral edge of the second lower strap; and wherein the first upperlateral edge, includes a first upper rounded or tapered portionincluding a part of the first upper patient-contacting fabric materiallayer and a part of the first upper outwardly facing loop materiallayer; wherein the second upper lateral edge, includes a second upperrounded or tapered portion including a part of the second upperpatient-contacting fabric material layer and a part of the second upperoutwardly facing loop material layer; wherein the first lower lateraledge, includes a first lower rounded or tapered portion including a partof the first lower patient-contacting fabric material layer and a partof the first lower outwardly facing loop material layer; and wherein thesecond lower lateral edge, includes a second lower rounded or taperedportion including a part of the second lower patient-contacting fabricmaterial layer and a part of the second lower outwardly facing loopmaterial layer.
 4. The respiratory mask assembly of claim 1, wherein therear portion is constructed and arranged to remain relatively fixed inposition in use; wherein the rear loop is adapted to extend along thepatient's parietal and zygomatic bones, and the rear loop comprises arigidizer between the first fabric layer and the second fabric layer,wherein the rigidizer is formed of a material selected from the groupconsisting of: nylon, polypropylene, polycarbonate, polystyrene,polyethylene, thermoplastic elastomer, thermoplastic urethane, silicone,and polyester; wherein the rear loop is constructed and arranged toassume a predetermined shape when not in use; wherein rear loopcomprises a self-supporting structure; wherein the at least a portion ofthe rear loop is extensible up to less than 5% under forces normallyencountered in use of the respiratory mask assembly, wherein the rearloop is bendable; wherein at least one of said first upper strap andsecond upper strap, and said first lower strap and second lower strap isconfigured to removably associate the rear loop with the mask; whereinthe rear loop is arched such that in use an upper portion of the rearloop extends along a first plane such that the upper portion lies flaton a crown of the patient's head, and wherein a lower portion of therear loop extends along a second plane such that the lower portion ofthe rear loop lies flat on a back of the patient's head, wherein thefirst plane is substantially orthogonal to the second plane; and whereinthe rear loop comprises a thickened portion, wherein the thickenedportion assists in maintaining a shape of some or part of the headgearsystem.
 5. The respiratory mask assembly of claim 4, wherein therigidizer is between 0.5 mm and 5 mm thick.
 6. The respiratory maskassembly of claim 1, wherein the headgear system includes at least onerigidizer constructed of rigid or semi-rigid material; wherein therigidizer has the same width as the first and second fabric layer;wherein stretch characteristic are approximately equal on both sides ofsaid first upper strap and second upper strap and said first lower strapand second lower strap; wherein the rigidizer is located between thefirst fabric layer and the second fabric layer; wherein the rigidizer iscompletely encapsulated by the first fabric layer and the second fabriclayer; wherein at least one of the first and second fabric layers islaminated onto foam; and wherein at least a portion of the rear portionis thicker than said first upper strap and second upper strap and saidfirst lower strap and second lower strap.
 7. The respiratory maskassembly of claim 6, wherein the rigidizer is neither elastic norextendible along its length.
 8. The respiratory mask assembly of claim1, wherein the rear loop includes an upper portion, wherein the upperportion extends from the first upper strap to the second upper strap,wherein the rear loop is angled at approximately 90 degrees from thefirst upper strap and approximately 90 degrees from the second upperstrap when worn by the patient, and wherein said first lower strap andsecond lower strap extend at an angle from the rear portion with respectto a horizontal plane, wherein the angle is about 10-30 degrees from thehorizontal plane.
 9. The respiratory mask assembly of claim 8, whereinthe rear loop has a variable width and an inner edge and an oppositeouter edge, a first rear loop width measured from the inner edge to thefirst join being greater than a second rear loop width measured from theinner edge to the outer edge at a location between the first join andthe first lower join.
 10. The respiratory mask assembly of claim 9,wherein the inner edge of the rear loop defines an opening, the openingbeing substantially circular, an upper portion of the opening configuredto accept the parietal bones of the patient and a lower portion of theopening configured to accept an occiput bone of the patient.
 11. Arespiratory mask assembly for treatment of sleep disordered breathing ina patient, comprising: a mask; a headgear system comprising: a rearportion having a closed rear loop to engage and circumscribe a back ofthe patient's head, the rear loop having a variable width and an inneredge and an opposite outer edge; a first upper strap and a second upperstrap each attached to the rear loop via stitching, the first upperstrap attached at a first join, the second upper strap attached at asecond join, a first rear loop edge of the rear loop abutting a firstupper strap edge of the first upper strap at the first join, a secondrear loop edge of the rear loop abutting an edge of the second upperstrap at the second join; a first lower strap and second lower strapeach attached to the rear portion via stitching, the first lower strapattached at a first lower join, the second lower strap attached at asecond lower join, a first rear portion edge of the rear portionabutting a first lower strap edge of the first lower strap at the firstlower join, a second rear portion edge of the rear portion abutting ansecond lower strap edge of the second lower strap at the second lowerjoin; a first rear loop width measured from the inner edge to the firstjoin being greater than a second rear loop width measured from the inneredge to the outer edge at a location between the first join and thefirst lower join; wherein the first lower strap and the second lowerstrap are each configured to extend below the patient's ears in use;wherein a first upper hook portion is located proximate a free end ofthe first upper strap, a second upper hook portion is located proximatea free end of the second upper strap, a first lower hook portion islocated proximate a free end of the first lower strap, and a secondlower hook portion is located proximate a free end of the second lowerstrap; wherein the first upper strap has a first upper length spanningbetween the first join and the first upper hook portion, the secondupper strap has a second upper length spanning between the second joinand the second upper hook portion, and the first lower strap has a firstlower length spanning between the first lower join and the first lowerhook portion, the second lower strap has a second lower length spanningbetween the second lower join and the second lower hook portion; whereinsaid first upper length is relatively more extensible than the firstlower length, and the second upper length is relatively more extensiblethan the second lower length; wherein the first upper strap isconstructed from a laminate having at least a first fabric layer and asecond fabric layer, the first fabric layer being constructed andarranged to be located on a non-patient-contacting side in use, andfurther wherein the first fabric layer and the second fabric layer arejoined at a first longitudinal edge joint and a second longitudinal edgejoint; wherein the first fabric layer and the second fabric layer arejoined along each said first longitudinal edge joint and secondlongitudinal edge joint; wherein the first longitudinal edge joint ispositioned at approximately a center or middle of a first lateral edgewhen viewed in cross section and the second longitudinal edge joint ispositioned at approximately a center or middle of a second lateral edgewhen viewed in cross section; wherein the mask is secured to thepatient's head with only four points of attachment including the firstupper strap, the second upper strap, the first lower strap and thesecond lower strap; and wherein the first upper strap, the second upperstrap, first lower strap, and the second lower strap arelength-adjustable via a hook and loop connection.
 12. The respiratorymask assembly according to claim 11, wherein the rear portion isconstructed and arranged to remain relatively fixed in position in use;wherein the rear portion includes a top strap configured to extend alongthe patient's parietal bones; wherein the rear portion includes a firstupper arm extending transverse from the rear loop and second upper armextending transverse from the rear loop, wherein the first upper strapremovably associates a first portion of the mask to the first upper arm,and the second upper strap removably associates a second portion of themask to the second upper arm; wherein the rear portion includes a baseportion, wherein the rear loop includes a left side portion and rightside portion, wherein at the base portion, the right side portion andthe left side portion of the rear loop are stitched to each other;wherein a vertical length of the base portion of the rear portion isbetween 30 and 60 mm; wherein the rear loop is arched such that in usean upper portion of the rear loop extends along a first plane such thatthe upper portion lies flat on a crown of the patient's head, andwherein a lower portion of the rear loop extends along a second planesuch that the lower portion of the rear loop lies flat on a back of thepatient's head, wherein the first plane is substantially orthogonal tothe second plane; wherein, in use, said first upper strap and secondupper strap extend above the patient's eyes from the rear loop to themask; wherein said first upper strap and second upper strap attach to aforehead support portion of the mask; wherein said first lower strap andsecond lower strap are each attached to the mask via clips; wherein aconformable material is located between said first fabric layer andsecond fabric layer; wherein each said first longitudinal edge joint andsecond longitudinal edge joint is positioned away from a face of thepatient during use; and wherein at least the first upper strap has afirst rounded lateral edge when viewed in cross section.
 13. Therespiratory mask assembly according to claim 12, wherein the rearportion comprises a thickened portion, wherein the thickened portionassists in maintaining a shape of some or part of the rear portion;wherein stretch characteristics are approximately equal on both sides ofsaid first upper strap and second upper strap, and said first lowerstrap and second lower strap; wherein at least one of said first fabriclayer and second fabric layer is laminated onto foam; wherein anon-woven material is inserted between said first fabric layer andsecond fabric layer; wherein the base portion includes a rigidizer,wherein the rigidizer includes stitched regions to stiffen the baseportion, wherein the stitched regions compress an interior layer of thebase portion, wherein the stitched regions are spaced from a baseportion edge of the base portion; and wherein said first upper strap andsecond upper strap each have the same width as each of said first lowerstrap and second lower strap.
 14. The respiratory mask assemblyaccording to claim 11, wherein the rear loop includes an upper portion,wherein the upper portion extends from the first upper strap to thesecond upper strap, wherein the rear loop is angled at approximately 90degrees from the first upper strap and approximately 90 degrees from thesecond upper strap when worn by the patient, and wherein said firstlower strap and second lower strap extend at an angle from the rearportion with respect to a horizontal plane, wherein the angle is about10-30 degrees from the horizontal plane.
 15. The respiratory maskassembly according to claim 14, wherein the inner edge of the rear loopdefines an opening, the opening being substantially circular, an upperportion of the opening structured to accept the parietal bones of thepatient and a lower portion of the opening structured to accept anocciput bone of the patient.
 16. The respiratory mask assembly accordingto claim 15, wherein the rear loop includes a base portion, the rearloop being pre-configured to engage with different planes of thepatient's head, the upper portion being pre-configured to extend in afirst plane to engage with a crown of the patient's head, the baseportion of the rear loop being pre-configured to extend along a secondplane, wherein the first plane is substantially orthogonal to the secondplane; and wherein the base portion is adapted to cup the patient'socciput.
 17. The respiratory mask assembly according to claim 11,wherein the rear loop includes an upper portion that extends along theparietal bones of the patient's head during use, wherein the upperportion is extensible up to less than 5% under force normallyencountered in use of the respiratory mask assembly, and wherein each ofsaid first lower strap and the second lower strap is extensible up toless than 5% under forces normally encountered in use of the respiratorymask assembly.
 18. A respiratory mask assembly for treatment of sleepdisordered breathing in a patient, comprising: a mask; a headgear systemincluding a plurality of straps cooperative with the mask and permittingadjustable fit of the mask, the plurality of straps comprising: a rearportion having a closed rear loop with a rear strap to engage andcircumscribe a back of the patient's head; a first upper strap andsecond upper strap each attached to the rear strap via stitching, thefirst upper strap attached at a first join, the second upper strapattached at a second join, the first upper strap adjustably associatedwith to a first part of the mask, the second upper strap adjustablyassociated with a second part of the mask; a first lower strap andsecond lower strap each attached to the rear strap via stitching, thefirst lower strap attached at a first lower join, the second lower strapattached at a second lower join, the first lower strap adjustablyassociated with a third part of the mask, the second lower strapadjustably associated with a fourth part of the mask; wherein at leastthe rear strap of the rear portion is constructed from a laminate havingat least a first fabric layer and a second fabric layer, the firstfabric layer being constructed and arranged to be located on anon-patient-contacting side in use, and further wherein the first fabriclayer and the second fabric layer are joined at a joint, and wherein atleast the rear strap has a first rounded lateral edge when viewed incross section; wherein each said joint is positioned at approximately acenter or middle of the first rounded lateral edge when viewed in crosssection; and wherein the rear strap includes a first rear strap portionand a second rear strap portion; wherein the first rear strap portionextends continuously in one piece from a first bottom edge of the rearportion to at least beyond the first join, wherein the first rear strapterminates at the first bottom edge, the second rear strap portion ofthe rear strap extends continuously in one piece from a second bottomedge of the rear portion to at least beyond the second join, wherein thesecond rear strap portion terminates at the second bottom edge; whereina first strap lower edge of the first lower strap aligns with the firstbottom edge of the first rear strap portion; wherein a second straplower edge of the second lower strap aligns with the second bottom edgeof the second rear strap portion and wherein the rear loop is archedsuch that in use an upper portion of the rear loop extends along a firstplane such that the upper portion lies flat on a crown of the patient'shead, and wherein a lower portion of the rear loop extends along asecond plane such that the lower portion of the rear loop lies flat on aback of the patient's head, wherein the first plane is substantiallyorthogonal to the second plane.
 19. The respiratory mask assembly ofclaim 18, wherein the rear portion is constructed and arranged to remainrelatively fixed in position in use wherein the headgear system furthercomprises a rigidizer adapted to extend along the patient's parietalbones; wherein the rear loop is arranged to assume a predetermined shapewhen not in use; wherein rear loop is a self-supporting structure;wherein the rear strap is configured to extend along the patient'sparietal bones behind the patient's ears, wherein the at least a portionof the rear loop is extensible up to less than 5% under forces normallyencountered in use of the respiratory mask assembly; wherein at leastone of said first upper strap and second lower strap and said firstlower strap and second lower strap is configured to removably associatethe rear strap to the mask; wherein the headgear system comprises athickened portion, wherein the thickened portion assists in maintaininga shape of some or part of the headgear system; wherein the mask issecured with 4 point attachment by said first upper strap and secondupper strap and said first lower strap and second lower strap; wherein afirst upper hook portion is located proximate a free end of the firstupper strap, a second upper hook portion is located proximate a free endof the second upper strap, a first lower hook portion is locatedproximate a free end of the first lower strap, and a second lower hookportion is located proximate a free end of the second lower strap;wherein the rigidizer is formed of a material selected from the groupconsisting of: nylon, polypropylene, polycarbonate, polystyrene,polyethylene, thermoplastic elastomer, thermoplastic urethane, silicone,and polyester; wherein the first fabric layer is formed of a firstfabric material that has different properties than a second fabricmaterial of the second fabric layer; and wherein the first fabric layerand the second fabric layer directly contact one another along each saidjoint, wherein the joint is selected from the group consisting of: anultrasonic weld joint, a heat sealed joint, and a computer numericalcontrolled knife joint.
 20. The respiratory mask assembly of claim 19,wherein each said first upper strap and second upper strap, and eachsaid first lower strap and second lower strap comprises apatient-contacting layer and an outwardly-facing loop material layer,the patient-contacting layer of said the first upper strap and secondupper strap, and said first lower strap and second lower strap isconstructed and arranged to engage the patient's head while in use, andwherein mutual edges of the patient-contacting layer and form a strapjoint positioned, as seen in cross-section, at a lateral edge of each ofsaid first upper strap and second upper strap and said first lower strapand second lower strap; wherein each lateral edge includes a rounded ortapered portion including a part of the patient-contacting layer and apart of the outwardly-facing loop material layer; and wherein thepatient-contacting layer is formed of a third fabric material that hasdifferent properties than a fourth fabric material that forms theoutwardly-facing loop material layer.
 21. The respiratory mask assemblyof claim 18, wherein the headgear system includes at least one rigidizerconstructed of rigid or semi-rigid material; wherein the rigidizer hasthe same width as the first fabric layer and second fabric layer;wherein stretch characteristics are approximately equal on both sides ofsaid the first upper strap and second upper strap, and said first lowerstrap and second lower strap; wherein the rigidizer is located betweenthe first fabric layer and the second fabric layer; wherein therigidizer is completely encapsulated by the first fabric layer and thesecond fabric layer; wherein at least one of the first fabric layer andsecond fabric layer is laminated onto foam; and wherein at least aportion of the rear loop is thicker than the said first upper strap andsecond upper strap and said first lower strap and second lower strap.22. The respiratory mask assembly of claim 21, wherein the rigidizer isneither elastic nor extendible along its length.
 23. The respiratorymask assembly of claim 21, wherein the rigidizer is between 0.5 mm and 5mm thick.
 24. The respiratory mask assembly of claim 18, wherein saidfirst lower strap and second lower strap extend at an angle from therear portion with respect to a horizontal plane, wherein the angle isabout 10-30 degrees from the horizontal plane.
 25. The respiratory maskassembly of claim 18, wherein the upper portion extends from the firstupper strap to the second upper strap, wherein the rear loop is angledat approximately 90 degrees from the first upper strap and approximately90 degrees from the second upper strap when worn by the patient.
 26. Therespiratory mask assembly of claim 25, wherein the rear loop has avariable width and an inner edge and an opposite outer edge, a firstrear loop width measured from the inner edge to the first join beingdifferent than a second rear loop width measured from the inner edge tothe outer edge at a location between the first join and the first lowerjoin.
 27. The respiratory mask assembly of claim 18, wherein the firstrear strap portion and the second rear strap portion are formed as onepiece.
 28. A respiratory mask assembly for treatment of sleep disorderedbreathing in a patient, comprising: a mask; a headgear comprising: astrap that connects to the mask, wherein when worn the strap forms arear loop that extends along a patient's occiput of in a rear portion ofthe strap and the strap also extends to a front of the patient's head;wherein the rear loop of the strap is configured to extend along thepatient's parietal bones; a portion of the rear loop of the strap isextensible; wherein the strap includes a first front portion and asecond front portion, the first front portion connected to the rearportion at a first join, the second front portion connects to the rearportion at a second join; wherein each of said first front portion andsecond front portion removably connects the rear portion of the strap tothe mask via clips; wherein the first front portion includes a firsthook portion proximate a free end of the first front portion, and thesecond front portion includes a second hook portion proximate a free endof the second front portion; wherein when used the patient's eyes andears are unobstructed by the headgear; wherein the rear portion isconstructed and arranged to remain relatively fixed in position on thepatient's head in use; wherein the rear portion has a differentextensibility than each of said first front portion and said secondfront portion; wherein the first front portion has a first lengthspanning between the first join and the first hook portion, the secondfront portion has a second length spanning between the second join andthe second hook portion, wherein the first length is extensible up toless than 5% under forces normally encountered in use of the respiratorymask assembly and the second length is extensible up to less than 5%under forces normally encountered in use of the respiratory maskassembly; and wherein stretch characteristics are approximately equal onboth sides of the rear loop.
 29. The respiratory mask assembly accordingto claim 28, wherein the mask is a nasal mask; wherein the mask issecured with 2 point attachment by said first front portion and secondfront portion; wherein the mask is secured to the patient's head withonly two points of attachment including the first front portion and thesecond front portion; wherein at least the rear portion of the strap isconstructed from a laminate having at least a first fabric layer and asecond fabric layer, the first fabric layer being constructed andarranged to be located on a patient-contacting side in use, and thesecond fabric layer being constructed and arranged to be located on anon-patient-contacting side in use, wherein the first fabric layer andthe second fabric layer are joined at a first longitudinal edge jointand a second longitudinal edge joint; wherein the first longitudinaledge joint is positioned at approximately a center or middle of a firstlateral edge when viewed in cross section and the second longitudinaledge joint is positioned at approximately a center or middle of a secondlateral edge when viewed in cross section; and wherein each said firstlongitudinal edge joint and second longitudinal edge joint is selectedfrom the group consisting of: an ultrasonic weld joint, a heat sealedjoint, and a computer numerical controlled knife joint.
 30. Therespiratory mask assembly according to claim 28, wherein the strapincludes a first upper strap, a second upper strap, a first lower strapand a second lower strap; wherein the first upper strap connects to therear portion at a first upper join, the second upper strap connects tothe rear portion at a second upper join; wherein the first front portioncomprises a portion of the first lower strap and the second frontportion comprises a portion of the second lower strap; wherein saidfirst upper strap and second upper strap removably attach to a foreheadsupport portion of the mask; wherein first upper strap includes a firstupper hook portion proximate a free end of the first upper strap, andthe second upper strap includes a second upper hook portion proximate afree end of the second upper strap; wherein said first upper strap andsecond upper strap have the same width as said first lower strap andsecond lower strap; wherein the first upper strap has a first upperlength spanning between the first upper join and the first upper hookportion, the second upper strap has a second upper length spanningbetween the second upper join and the second upper hook portion; whereinthe first upper length is relatively more extensible than the firstlength, and the second upper length is relatively more extensible thanthe second length; wherein the mask is secured to the patient's headwith only four points of attachment including the first upper strap, thesecond upper strap, the first lower strap and the second lower strap;wherein the rear loop is arched such that in use an upper portion of therear loop extends along a first plane such that the upper portion liesflat on a crown of the patient's head, and wherein a lower portion ofthe rear loop extends along a second plane such that the lower portionof the rear loop lies flat on a back of the patient's head, wherein thefirst plane is substantially orthogonal to the second plane; wherein atleast the rear loop is constructed from a laminate having at least afirst fabric layer and a second fabric layer, the first fabric layerbeing constructed and arranged to be located on a patient-contactingside in use, and the second fabric layer being constructed and arrangedto be located on a non-patient-contacting side in use, wherein the firstfabric layer and the second fabric layer are joined at a firstlongitudinal edge joint and a second longitudinal edge joint; whereinthe first longitudinal edge joint is positioned at approximately acenter or middle of a first lateral edge when viewed in cross sectionand the second longitudinal edge joint is positioned at approximately acenter or middle of a second lateral edge when viewed in cross section;wherein each said first longitudinal edge joint and second longitudinaledge joint is selected from the group consisting of: an ultrasonic weldjoint, a heat sealed joint, and a computer numerical controlled knifejoint; wherein the rear loop is adjustable; and wherein in use each ofthe first upper strap and second upper strap extends above the patient'seyes.